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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K212412
Device Name IRIS-XP
Applicant
Medicore Co., Ltd.
Seongnam-Si,  KR 13207
Applicant Contact Kyo-bum Kim
Correspondent
Gms Consulting
4th Floor, Digital Cube, 34, Sangamsan-Ro
Seoul,  KR 03909
Correspondent Contact DoGyun Lim
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received08/03/2021
Decision Date 09/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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